Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
This study is currently recruiting participants.
Verified March 2013 by McMaster University
Sponsor:
Hamilton Health Sciences Corporation
Collaborator:
Janssen-Ortho Inc., Canada
Information provided by (Responsible Party):
M. Van Ameringen, McMaster University
ClinicalTrials.gov Identifier:
NCT00182520
First received: September 14, 2005
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: Topiramate Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression - Improvement ≤ 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Montgomery Asberg Depression Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Sheehan Disability Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- PI-SWUR Hoarding Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Self Report Y-BOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Topiramate
|
Drug: Topiramate
25 mg - 400 mg/day x 12 weeks
Other Name: Topomax
|
|
Placebo Comparator: 2
placebo
|
Drug: placebo
25 - 400 mg/day x 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatient with primary DSM- IV OCD
- Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of < 35%)
- Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.
Exclusion Criteria:
- Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
- A previous adequate trial of topiramate
- Comorbid major depressive disorder diagnosis which predates OCD diagnosis
- Cognitive behavioural therapy or additional psychotherapy in past four months
- Allergy or hypersensitivity to topiramate
- BMI < 20
- History of kidney stones
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182520
Contacts
| Contact: Beth E Patterson, BScN, BEd | 905-921-7644 | bpatter@mcmaster.ca |
Locations
| Canada, Ontario | |
| MacAnxiety Research Centre | Recruiting |
| Hamilton, Ontario, Canada, L8S 1B7 | |
| Contact: Beth Patterson, BScN, BEd 905-921-7644 bpatter@mcmaster.ca | |
| Sub-Investigator: Catherine Mancini, MD, FRCPC | |
| Sub-Investigator: Steve Collins, MB, FRCPC | |
| Sub-Investigator: Jonathan Oakman, PhD | |
| Principal Investigator: Michael Van Ameringen, MD, FRCPC | |
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Janssen-Ortho Inc., Canada
Investigators
| Principal Investigator: | Michael VanAmeringen, MD, FRCPC | McMaster University |
More Information
No publications provided
| Responsible Party: | M. Van Ameringen, Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00182520 History of Changes |
| Other Study ID Numbers: | 01-133 |
| Study First Received: | September 14, 2005 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
Treatment Refractory Obsessive Compulsive Disorder |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Topiramate Serotonin Uptake Inhibitors Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013